The Lung Microbiome in Sarcoidosis

NCT02520323 | Completed

• 1 other identifier: HUM00095799
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the presence of bacterial species, and the immunologic and molecular mechanisms of granuloma formation that might be involved in the pathogenesis of sarcoidosis. The investigators will collect peripheral blood and bronchoalveolar lavage fluid samples to isolate bacterial DNA and blood monocytes and lymphocytes. Specimens will be obtained from patients with sarcoidosis, with non-sarcoid lung disease, and healthy volunteers to directly compare the bacterial species present and the characteristics of cells thought to be involved in granuloma formation.

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Microbiome analysis

  To assess the microbiome profile in lung lavage fluid and peripheral blood of subjects

  Baseline

Secondary Outcomes (1)

• Measures of immunologic phenotype

  Baseline

Study Arms (2)

Blood only

20 sarcoidosis subjects and 20 healthy controls will complete lifestyle questionnaires and have blood drawn for microbiome analyses.

Other: Blood draw; Behavioral: Questionnaires

Blood and BAL

10 sarcoidosis subjects, 10 healthy controls, and 10 subjects with non-sarcoid interstitial lung disease will complete lifestyle questionnaires and undergo blood sampling for microbiome analyses as well as bronchoscopy for bronchoalveolar lavage microbiome analyses.

Other: Blood draw; Procedure: Bronchoscopy; Behavioral: Questionnaires

Interventions

Blood draw OTHER

Blood and BAL; Blood only

Bronchoscopy PROCEDURE

Blood and BAL

Questionnaires BEHAVIORAL

Blood and BAL; Blood only

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects will be patients with sarcoidosis (involving any organ system), with non-sarcoid interstitial lung disease, and healthy controls.

You may qualify if:

• Clinical diagnosis of sarcoidosis (30 subjects) or
• Clinical diagnosis of non-sarcoid interstitial lung disease (10 subjects) or
• Age-matched controls (30 subjects)
• Ability to provide informed consent

You may not qualify if:

• Any disease condition (such as anemia, unstable cardiac disease, etc.) that in the opinion of the subject's primary physician would put the patient at risk of harm from having 60 cc of blood drawn or for undergoing bronchoscopy for this study.
• Patients who are undergoing bronchoscopy for presumed infection.
• Pregnant women, women who may be pregnant, and women who are breastfeeding.
• Patients who have undergone lung transplantation.
• Persons who are unable or unwilling to undergo bronchoscopy, including those unable to be accompanied by a designated driver to the procedure.
• Persons who have taken antibiotics in the 90 days prior to consent.
• Known HIV, HCV, alcohol, or other substance abuse history.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sarcoidosis

Interventions

Blood Specimen Collection; Bronchoscopy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Respiratory System; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric S White, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 11, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 5, 2017

Record last verified: 2017-06

Locations

US (1)